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Short Course 2: The Future of Regulatory Affairs


Instructors

  • Michiel  Stam

    Michiel Stam

    • Head of Data Management and Regulatory Information Scientist
    • Qdossier, Netherlands

    Michiel Stam works as a Regulatory Information Scientist and is heading the Data Management group at Qdossier. He is a specialist in electronic submissions and regulatory information management and worked for various Pharma and Biotech companies in the past 10 years. Michiel has a strong focus on registration tracking, master data management, XEVMPD and IDMP.

  • Hans  van Bruggen, MSc

    Hans van Bruggen, MSc

    • CEO and Senior RA Consultant
    • Qdossier, Netherlands

    Hans van Bruggen has an MSc in Pharmaceutical Medicine from the University of Surrey and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. He has gained a wealth of experience and a comprehensive view on what information is needed to evaluate the benefit/risk ratio of medicinal products for patients. Using that scientific background he approaches interdisciplinary and international processes. Hans has been involved with eCTD submissions from the beginning, back in 2000. Key areas of expertise include: lean authoring of regulatory documents, managing regulatory information and lean data, document and dossier management focusing on reuse rather then recreate.

  • Wim  Cypers, MPharm

    Wim Cypers, MPharm

    • SVP Regulatory
    • ArisGlobal, United States

    Wim Cypers has been with ArisGlobal for 23 years. In his current role, he heads all business unit operations for our regulatory domain, including overall product vision, strategy, implementation, and success of ArisGlobal’s Regulatory Solution Suite. Wim has long standing experience in converting business requirements into application functionality; and consistently showing industry thought leadership through speaking engagements at several industry events. He has applied his pharmacist training into a keen understanding of how to solve complex business issues. Before focusing exclusively on ArisGlobal’s Regulatory Business Unit, Wim managed the company’s strategy and product management function for both the safety and regulatory solutions.